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Will Open Source software become ...

Posted Nov 10 2008 4:19pm

Will Open Source software become the norm in time when it comes to compiling and referencing Clinical Trial information?  There are quite a few alternatives here such as PHP and Postgre SQL and as web based technologies continue to grow, no doubt this question will continue to arise..." Cynthia Brandt and Prakash Nadkarni of the Yale Center for Medical Informatics, with their TrialDB system (http://ycmi.med.yale.edu/trialdb/), have championed a non-commercial approach since the 1990s. [9] However, although their software is freely available, its use is targeted to either Oracle's Database Management System or Microsoft's SQL Server"... and license purchases are still a big concern and expense...but without the commercial data bases, the open source software may not be in existence...with web 2.0 continuing to emerge, no doubt there will be opportunities for compiling information with open source software...Clinical Trial data where it can be accessed by all could be a step in the right direction...BD 

In Europe, it is a legal requirement to conduct clinical trials in accordance with the International Conference on Harmonisation's guidelines on good clinical practice (see http://www.ich.org /). A recent editorial reported that this directive has led to a decline in the number of trials being conducted by independent academic groups. [1] One possible reason for this is that reporting and documentation requirements are now so burdensome that the process has become unnecessarily complicated. [2] This is rather ironic, given that well-designed clinical trials should be amenable to very simple data handling and analysis. [3] Indeed the flowchart established by the CONSORT (Consolidated Standards of Reporting Trials) statement [4] for carrying out a properly randomised controlled trial has just four steps, which supports the approach of keeping it simple.

Research organizations and funders should combine efforts to produce an open-source solution for trial data management. A shared platform could then be easily established, and would bring wider benefits such as electronic submission to regulators, automated sharing of data, and contribution to important public databases such as pharmacovigilance and drug-monitoring registries.

Open-Source Clinical Trial Data-Management System?

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